Convertors
Impervious Stockinette Intermediate BNS
32manufacturers in China registered for this device type
12catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (12), Guangdong (6), Zhejiang (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Steriger Sports Medicine Technology Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 11 |
| Zengcheng Hua Chang Plastic & Metal Moulding Company Limited | Zengcheng | Guangdong | Contract manufacturer | 6 |
| Zhejiang Yiheng Textile Technology Co., Ltd. | Zhuji | Zhejiang | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
Showing 12 of 32. All 32 manufacturers in China registered for Stocking, Elastic
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | ILG |
| Device type | Stocking, Elastic |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-06-22 |
| Record revised | 2026-02-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, case of 4, case of 3, case of 20 |
| Distribution end date | 2025-07-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1587 | In distribution | ||
| 1585 | In distribution | ||
| 1586 | In distribution | ||
| 8430 | In distribution | ||
| 1586N | 140 | In distribution | |
| 1582NB | 2,250 | In distribution | |
| 1584 | In distribution | ||
| 1586 | Withdrawn | ||
| 1585 | Withdrawn | ||
| 1584 | Withdrawn | ||
| 8430 | Withdrawn | ||
| 1587 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 159 |
| Vive | Vive Health LLC | 29 |
| Bunion Bootie | SLO Living LLC | 10 |
| Cotton Underliner | Sigvaris, Inc. | 6 |
| BunionETTE Bootie | SLO Living LLC | 6 |
| Surgyco | Surgyco LLC | 4 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 3 |
| Tournisec | 62K Solutions, LLC | 2 |
| AUM | Slv Pharmaceuticals LLC | 1 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-02-25 | Class II | Nonconforming Material/Component | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly. | 1020 units | 2024-01-09 |
| 2021-02-25 | Class II | Nonconforming Material/Component | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly. | 28417 units | 2024-01-09 |
| 2021-02-25 | Class II | Nonconforming Material/Component | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly. | 21343 units | 2024-01-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.